Senior Regulatory Affairs Professional for Regional Operations

6 days ago

Dublin, Dublin City, Ireland beBeeCareer Full time
Regulatory Affairs Manager, Europe Job Summary

This is an opportunity for a seasoned Regulatory Affairs Manager to join our team and manage regulatory regional operational activities in support of maintaining regulatory compliance of products throughout the region.

The successful candidate will be responsible for coordinating and/or executing regulatory operational activities related to new marketing authorizations and lifecycle submissions across the region. They will ensure labelling maintenance and compliance and support the translation process as required.

Key Responsibilities:
  • Coordinate and/or execute regulatory operational activities related to new marketing authorizations and lifecycle submissions across the region.
  • Ensure labelling maintenance and compliance and support the translation process as required.
  • Maintain compliance for all marketing authorisations in Europe, including those held by third parties on behalf of iNova.
  • Ensure efficient and consistent implementation and use of internal and external regulatory databases and systems.
  • Coordinate and supervise change management regulatory assessments in the region, as needed.
  • Adopt and align iNova's regulatory information management system with other organisational systems.
  • Support cross-regional regulatory collaboration and harmonisation to achieve business and compliance objectives.
  • Support business innovation initiatives assessments and regulatory due diligence for new products as required.
  • Provide regulatory support for major commercial expansion projects in the region and support the creation or update of dossiers to enable product registrations and lifecycle submissions.
  • Support the regulatory intelligence regional process, to coordinate action or mitigation plans when required.
  • Develop and maintain strong relationships with internal business teams and relevant external parties, and communicate with these parties in a timely and effective manner.
  • Participate on internal cross-regional or cross-functional initiatives, as appropriate.
Requirements
  • Recognised pharmacy, medical or relevant science university degree.
  • Minimum 4-5 years' experience in the pharmaceutical industry, with at least 3 years' experience in European (EU) countries.
  • Good pharmacological/pharmaceutical/clinical knowledge.
  • Solid understanding of regulatory requirements for medicines, medical devices, and complementary medicines.
  • Strong knowledge of global regulatory frameworks.
  • Familiar with fundamental principles of clinical, regulatory, registration and compliance issues in the EU region.
  • Good project planning and organisational skills with a high degree of multi-project tasking.
  • Effective communicator in matrix environments.
  • Strong interpersonal, influencing, and teamwork skills.
  • Fluent in English (written and spoken); additional languages are an advantage.
Additional Requirements
  • Occasional business travel within the EU region may be required.

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